Breast cancer is the second most common cancer among women. Roughly 190,000 women in the U.S. will be diagnosed with breast cancer in 2009, and 40,000 will die. The majority of breast cancers originate in the lobular or ductal cells of the milk-producing glands. In these structures, there are two main cell types: the inner luminal cells surrounded by basal myoepithelium. These cells types are distinct and are the precursors to various forms of breast cancer. As such, it is it is important to study these cell populations independently as well as in co-culture models systems. There are no commercial sources of quality-controlled, matched basal and luminal cells (from individual donors), forcing researchers to isolate and characterize the cells on their own. This process is time-consuming, requires access to human tissue, and introduces variation in the preparation and characterization of the cells. Primary cultured human mammary-derived cells are an ideal model currently used to investigate the genesis and understanding of human breast cancer. Because a consistent commercial source of primary human cultured breast-derived luminal and basal cells is unavailable, Zen-Bio, Inc. will address this need by providing a well characterized system to the research community. Phase I of this project focused on generating an optimized primary human mammary-derived basal/luminal cell system from non-diseased tissue. Isolation and propagation of normal human basal and luminal mammary epithelial cells was achieved. Based on the successful completion of Phase I, we are eager to extend our research in Phase II by focusing on making this cell system commercially available. Additionally, we will expand the cell system to include basal and luminal mammary epithelial cells from breast tumor tissue. Aim 1 of this project is to continue detailed characterization of normal basal and luminal cells focusing on quality control and release criteria for commercialization. Aim 2 is to establish isolation and propagation procedures and detailed characterization of human breast cancer tumor derived cells building on our existing capabilities. Aim 3 is to perform comparative analyses between normal and malignant human cells to establish quality control criteria for commercialization and additional contract assay services at Zen-Bio. Multiple product offerings are expected from this proposal: matched, primary human mammary cell systems from non- diseased and malignant tissue, support media and reagents, contract assay services, and kits for breast cancer research. PUBLIC HEALTH RELEVANCE: At the completion of this project, a fully characterized human primary mammary-derived basal/luminal cell system from normal and malignant breast tissue will be commercially available to researchers. These systems will provide a currently unavailable opportunity to investigate the etiology of breast cancer and to identify potential cures.